Metronidazole 7.5 mg/g Cream, 45 g — NDC 0168-0323-46 (Billing 00168-0323-46)
This is a package of 45 g of Metronidazole 7.5 mg/g Cream from Fougera Pharmaceuticals, LLC, marketed since May 2004 and currently FDA-listed; retail pharmacies pay about $0.2571 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0168-0323-46 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0168 labeler · 0323 product · 46 package
- Package marketed since
- May 28, 2004
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 45 g per package
- Barcode (UPC)
- 0301680323466
- Medicaid fills, this package
- 63,560 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 041799
- GCN: 43203
- GPI-14 (Medi-Span): 90060040003710
- HICL (First Databank): 004157
- AHFS class code: 08:30.04.00
- RxCUI (RxNorm): 311678
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Oral forms treat trichomoniasis, and some also treat amebiasis and anaerobic infections. Vaginal gels treat bacterial vaginosis, and topical cream or lot...
- No. Alcohol with oral metronidazole can cause cramps, nausea, vomiting, headache and flushing. Avoid alcohol and products with propylene glycol during treatment and for at least th...
- The most common are nausea, headache, loss of appetite, vomiting, diarrhea and stomach cramps. A metallic taste is also common. Call your doctor if you notice numbness or tingling,...
- Yes. Metronidazole can interact with warfarin, lithium, busulfan, disulfiram and drugs that affect heart rhythm. Some of these combinations need blood tests or should be avoided, s...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metronidazole — tap one for details:
Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.257 | $11.57 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.5256 | $23.65 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $0.6934 | $31.20 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00168-0323-46 You're viewing this Main listing | 45 g in 1 TUBE | 2004-05-28 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metronidazole 7.5 mg/g 00713-0637-37 | Cosette | 1 tube | $0.179 | AB | Availability likely | save 30% |
| Metronidazole 7.5 mg/g 72578-0209-04 | Viona | 1 tube | $0.179 | AB | Availability likely | save 30% |
| Metronidazole 7.5 mg/gthis 00168-0323-46 | Fougera | 45 g | $0.257 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 00713-0633-37 | Cosette | 1 tube | $0.257 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 59651-0770-46 | Aurobindo | 1 tube | $0.257 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 66993-0960-45 | Prasco | 1 tube | $0.257 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 68308-0711-45 | Mayne | 1 tube | $0.257 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 72578-0129-08 | Viona | 1 tube | $0.257 | BX | Availability likely | — |
| metronidazole 7.5 mg/g 68308-0712-59 | Mayne | 1 bottle | $1.817 | AB | Availability likely | +607% |
| Metronidazole 7.5 mg/g 68788-8552-04 | Preferred | 1 tube | — | BX | FDA listed | — |
| Metronidazole 7.5 mg/g 70771-1834-04 | Zydus | 1 tube | — | BX | FDA listed | — |
| Metronidazole 7.5 mg/g 72162-2259-02 | Bryant | 45 g | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 51672-4116-02 | Sun | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 70771-1978-04 | Zydus | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 67296-2121-04 | Redpharm | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Metronidazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 8CRQ2TH63M
Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Fougera Pharmaceuticals, LLC labeler code 00168
- Betamethasone Dipropionate .5 mg/g Ointment, Augmented NDC 0168-0268-15
- Clobetasol Propionate .5 mg/mL Solution NDC 0168-0269-50
- Clindamycin Phosphate 20 mg/g Cream NDC 0168-0277-40
- Amcinonide 1 mg/g Cream NDC 0168-0278-15
- Clobetasol Propionate .5 mg/g Gel NDC 0168-0293-15
- Clobetasol Propionate (emollient) .5 mg/g Cream NDC 0168-0301-15
- Fluticasone Propionate .5 mg/g Cream NDC 0168-0332-15
- Terconazole 4 mg/g Cream NDC 0168-0346-46
- Terconazole Vaginal Cream 0.8% 8 mg/g Cream NDC 0168-0347-20
- Lidocaine and Prilocaine 25 mg/g; 25 mg/g Cream NDC 0168-0357-30
- Oxiconazole Nitrate 10 mg/g Cream NDC 0168-0358-30
- Metronidazole 7.5 mg/mL Lotion NDC 0168-0383-60
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of metronidazole topical cream.
⛔ Contraindications ▾
CONTRAINDICATIONS Metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.
The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
🔄 Drug Interactions ▾
Drug interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
🤰 Pregnancy ▾
Pregnancy: Teratogenic effects: Pregnancy category B There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice.
However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Metronidazole Topical Cream 0.75% is supplied in a 45 gram tube, NDC 0168-0323-46 Storage conditions: Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46273863A R07/2020 #29
📦 Storage and Handling ▾
Storage conditions: Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 46273863A R07/2020 #29
📋 Description ▾
DESCRIPTION Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid, and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-Methyl-5-nitroimidazole-1-ethanol.
The molecular formula is C 6 H 9 N 3 O 3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula: structure
💬 Information for Patients ▾
Information for patients: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
⚠️ Precautions ▾
PRECAUTIONS General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.
Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia. Information for patients: This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. Drug interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters. Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months.
However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months. Pregnancy: Teratogenic effects: Pregnancy category B There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly.
No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed. Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma.
Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric use: Safety and effectiveness in pediatric patients have not been established.
🍼 Nursing Mothers ▾
Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters. Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months.
However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE NDC 0168-0323-46 Fougera® METRONIDAZOLE TOPICAL CREAM 0.75% Rx only FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN. NET WT 45 grams 45gramTubeLabel
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON NDC 0168-0323-46 Rx only Fougera® METRONIDAZOLE TOPICAL CREAM 0.75% FOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE NET WT 45 grams 45gcarton